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Active, Not Recruiting

NCT Number: NCT05794178

Testing Responses of Young Adults to Intervention Messages for Promoting Physical Activity Trial

The goal of this clinical trial is to test a precision (person-specific and context-sensitive) messaging algorithm for increasing physical activity and slowing weight gain in insufficiently-active young adults. The main questions it aims to answer are:

* Does physical activity increase more when text messages are sent based on a precision rule for selecting and timing messages compared to when the same message content is selected and sent at random or not at all? * Do biological or social characteristics of young adults make them more likely to respond positively to the precision messaging intervention than either of the other two interventions?

Participants will be provided with education about health-enhancing physical activity and given an activity tracker to wear for 12 months. They will then be randomly assigned to one of three groups. Participants in one group (Precision AIM) will receive up to 4 messages/day selected and timed based on a person-specific algorithm that forecasts possible message effects periodically throughout the day. Messages will be drawn from one of three content libraries: move more, sit less, or inspirational quotes. Participants in a second group (Random AIM) will receive 4 messages/day selected at random from the same three content libraries and delivered at random times within their availability window. Participants in the third group (No AIM) will receive not motivational messages but will randomly assigned to the Random AIM group will receive up to 4 messages/day drawn at random from three content libraries at randomly-selected times. Step counts and weight will be assessed at baseline, and at 3 months, 6 months, 12 months, and 18 months. Researchers will compare Precision AIM, Random AIM and No AIM groups to see if physical activity increased more and weight gain was slower in Precision AIM than Random AIM or No AIM after 3, 6, and 12 months of intervention, and 6 months after the intervention is complete (18 months).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Physical Inactivity Behavior Body Weight Body Weight Changes Pathological Conditions, Signs and Symptoms Sedentary Behavior Signs and Symptoms Weight Gain

Age range

18 year–29 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan, Ann Arbor, Michigan, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • own an iPhone or Android smartphone that they would be willing to download the Fitbit app onto and sync with a Fitbit tracker and a custom, AIM app
  • willing to wear a Fitbit tracker almost continually (23.5 hours/day) for a 12- month period of time
  • free of visual impairment that would interfere with the receipt of text messages on their phone
  • capable of reading, speaking and understanding English and of giving informed consent
  • willing to complete a full 18-month study protocol

Exclusion criteria

  • self-report sufficient aerobic activity to meet 2018 Physical Activity Guidelines for American adults
  • research-grade accelerometer records sufficient aerobic physical activity to meet 2018 Physical Activity Guidelines for American adults
  • living outside the continental US
  • one or more contraindications to physical activity
  • require an assistive device for mobility or have any other condition that may limit or prevent participation in moderate-intensity physical activity
  • pregnant or planning to become pregnant within the next 12 months
  • prior diagnosis of cancer, cardiovascular disease, diabetes or metabolic syndrome
  • concurrent participation in another research study involving physical activity or weight loss
  • planning to have surgery or relocate outside the continental US within the next year.

Treatment and study plan

Education

Behavioral

Education about health benefits of physical activity, 2018 US Physical Activity Guidelines, assigned goals tailored to baseline step counts, and worksheet to develop action and coping plans (three of each)

Activity Tracker

Behavioral

Fitbit activity tracker and mobile app to provide ad libitum behavioral feedback and self-regulatory support

Text messaging (random timing and selection)

Behavioral

Four text messages/day at random times within a participant's availability window and drawn at random from one of three content libraries (move more [40%], sit less [40%], inspirational quotes [20%])

Text messaging (precision dosing)

Behavioral

Up to four text messages/day within a participant's availability window, timed and selected from one of three content libraries (move more, sit less, inspirational quotes) based on a person-specific dynamic model and contextual data

Primary outcomes

  1. Average daily step counts (6 months)

    Time frame: Change from baseline to 6 months

    Average daily step counts recorded by Actigraph accelerometer over a 7-day monitoring period

Secondary outcomes

  1. Average daily step counts (12 months)

    Time frame: Change from baseline to 12 months

    Average daily step counts recorded by Actigraph accelerometer over a 7-day monitoring period

  2. Average daily step counts (18 months)

    Time frame: Change from 12 months to 18 months

    Average daily step counts recorded by Actigraph accelerometer over a 7-day monitoring period

  3. Weight (6 months)

    Time frame: Change from baseline to 6 months

    Weight (kg) measured by BodyTrace scale

  4. Weight (12 months)

    Time frame: Change from baseline to 12 months

    Weight (kg) measured by BodyTrace scale

  5. Weight (18 months)

    Time frame: Change from 12 months to 18 months

    Weight (kg) measured by BodyTrace scale

  6. Moderate-to-vigorous intensity physical activity duration (6 months)

    Time frame: Change from baseline to 6 months

    Average duration of daily moderate (or higher) physical activity recorded by Actigraph accelerometer over a 7-day monitoring period

  7. Moderate-to-vigorous intensity physical activity duration (12 months)

    Time frame: Change from baseline to 12 months

    Average duration of daily moderate (or higher) physical activity recorded by Actigraph accelerometer over a 7-day monitoring period

  8. Moderate-to-vigorous intensity physical activity duration (18 months)

    Time frame: Change from 12 months to 18 months

    Average duration of daily moderate (or higher) physical activity recorded by Actigraph accelerometer over a 7-day monitoring period

  9. Light intensity physical activity duration (6 months)

    Time frame: Change from baseline to 6 months

    Average duration of daily light-intensity physical activity recorded by Actigraph accelerometer over a 7-day monitoring period

  10. Light intensity physical activity duration (12 months)

    Time frame: Change from baseline to 12 months

    Average duration of daily light-intensity physical activity recorded by Actigraph accelerometer over a 7-day monitoring period

  11. Light intensity physical activity duration (18 months)

    Time frame: Change from 12 months to 18 months

    Average duration of daily light-intensity physical activity recorded by Actigraph accelerometer over a 7-day monitoring period

  12. Sedentary behavior duration (6 months)

    Time frame: Change from baseline to 6 months

    Average duration of daily sedentary behavior physical activity recorded by Actigraph accelerometer over a 7-day monitoring period

  13. Sedentary behavior duration (12 months)

    Time frame: Change from baseline to 12 months

    Average duration of daily sedentary behavior recorded by Actigraph accelerometer over a 7-day monitoring period

  14. Sedentary behavior duration (18 months)

    Time frame: Change from 12 months to 18 months

    Average duration of daily sedentary behavior recorded by Actigraph accelerometer over a 7-day monitoring period

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Testing Responses of Young Adults to Intervention Messages (TRY AIM) for Promoting Physical Activity Trial

Acronym: TRY AIM

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Apr 3, 2023
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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